Regulatory and Biosafety Issues in Relation to Transgenic Animals in Food and Agriculture, Feeds Containing Genetically Modified Organisms (GMO) and Veterinary Biologics
Development of an effective regulatory system for genetically engineered animals and their products has been the subject of increasing discussion among researchers, industry and policy developers, as well as the public. Since transgenesis and cloning are relatively new scientific techniques, transgenic animals are new organisms for which there is limited information. The issues associated with the regulation and biosafety of transgenic animals pertain to environmental impact, human food safety, animal health and welfare, trade and ethics. To regulate this new and powerful technology predicated on limited background information is a challenge not only for the regulators, but also for the developers of such animals, who strive to prove that the animals are safe and merit bio-equivalency to their conventional counterparts. In principle, an effective regulatory sieve should permit safe products while forming a formidable barrier for those assessed of posing an unacceptable risk.
Adoption of transgenic technology for use in agriculture will depend upon various factors that range from perceived benefits for humans and animals, to safe propagation, animal welfare considerations and integrity of species, as well as effects on bio-diversity. A regulatory framework designed to address the concerns connected with the environmental release of transgenic animals needs to also take into account the ability of genetically modified animals to survive and compete with conventional populations. Regulatory initiatives for biotechnology-derived animals and their products should ensure high standards for human and animal health; a sound scientific basis for evaluation; transparency and public involvement; and maintenance of genetic diversity.
Feeds obtained by use of biotechnology have to be evaluated for animal and human safety by using parameters that define their molecular characterization, nutritional qualities and toxicological aspects, while veterinary biologics derived from biotechnology must be shown to be pure, potent, safe and effective when used according to label recommendations.
The Canadian regulatory system relies on the “precautionary principle” in its approach to regulate the “product” instead of the “process”. The regulatory framework captures transgenic animals under the Canadian Environmental Protection Act (CEPA). Food from transgenic animals is assessed for safety by Health Canada under its Novel Foods Regulations of the Food and Drugs Act. Feed containing any genetically modified organism is considered Novel Feed under the Feeds Act and Regulations. The regulation of veterinary biologics, in an effort to prevent and diagnose infectious diseases of animals, relies on effective science-based regulatory controls under the Health of Animals Act and Regulations. The Canadian system of regulation for feeds, veterinary biologics and transgenic animals could be useful to developing countries in the process of establishing an effective framework for new regulations.
KeywordsRegulatory Framework Transgenic Animal Genetically Modify Organism Genetically Modify Organism Spider Silk
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- Berkowitz, D.B. 1993. The food safety of transgenic animals: implications from traditional breeding. Journal of Animal Science, 7: 43–46.Google Scholar
- CCAC [Canadian Council on Animal Care]. 1997. CCAC guidelines on transgenic animals. Canadian Council on Animal Care, Ottawa, Ontario. Available at: http://www.ccac.ca/englishgdlines/transgen/transge1.htm#download.Google Scholar
- CFIA [Canadian Food Inspection Agency]. 1998. Session report on “Consultation on regulating livestock animal and fish derived from biotechnology”. Available at: http://www.inspection.gc.ca/english/sci/biotech/tech/aniconsulte.shtmlGoogle Scholar
- CFIA. 2003a. Canadian Food Inspection Agency-Feeds section. Available at: http://www.inspection.gc.ca/english/anima/feebet/feebete.shtmlGoogle Scholar
- CFIA. 2003b. Canadian Food Inspection Agency-Veterinary Biologics section. Available at: http://www.inspection.gc.ca/english/anima/vetbio/vbpbve.shtmlGoogle Scholar
- EC/HC [Environment Canada/Health Canada]. 2001. Guidelines for the notification and testing of New Substance organisms, pursuant to “The New Substances Notification Regulations of the Canadian Environmental Protection Act, 1999”. Published by Environment Canada and Health Canada.Google Scholar
- Howard, T.H., Homan, E.J. & Bremel, R.D. 2001. Transgenic livestock: Regulation and science in a changing environment. Journal of Animal Science, 79(Suppl.): 1–11.Google Scholar
- Maredia, M.K. 1998. The economics of biosafety: implications for biotechnology in developing countries. Biosafety, 3: 1–10.Google Scholar
- Nuffield. 1999. Nuffield Council on Bioethics in Genetically Modified Crops: The ethical and social issues. The Nuffield Foundation, London.Google Scholar
- Phelps, C.J., Koike, C., Vaught, T.D., Boone, J., Wells, K.D., Chen, S.H., Ball, S., Specht, S.M., Polejaeva, I.A., Monahan, J.A., Jobst, P.M., Sharma, S.B., Lamborn, A.E., Garst, A.S., Moore, M., Demetris, A.J., Rudert, W.A., Bottino, R., Bertera, S., Trucco, M., Starzl, T.E., Dai, Y. & Ayares, D.L. 2003. Production of alpha 1,3 galactosyltransferase-deficient pigs. Science, 299: 411–414.PubMedCrossRefGoogle Scholar
- Scientists’ Working Group on Biosafety. 1998. Manual for assessing ecological and human health effects of genetically engineered organisms. Edmonds, WA: Edmonds Institute.Google Scholar